蓝湾高纯度硫酸氨基葡萄糖治疗膝关节骨性关节炎的有效性和安全性研究  

Study on the efficacy and safety of Lanwan high purity glucosamine sulfate in the treatment of knee osteoarthritis

作　　者：薛延[1] 汪永利[2] 娄思权[3] 眭承志[4] 原晓景[5] 傅磊[6] 梁祥云 杨晓荣 XUE Yan;WANG Yong-li;LOU Si-quan;SUI Cheng-zhi;YUAN Xiao-Jing;FU Lei;LIANG Xiang-yun;YANG Xiao-rong(Beijing Institute of Traumatology and Orthopaedics,Beijing Jishuitan Hospital,Beijing 100035 ,China)

机构地区：[1]北京积水潭医院北京市创伤骨科研究所,北京100035 [2]国家体育总局运动医学研究所体育医院 [3]北京大学第三医院骨科 [4]厦门大学附属第一医院康复科 [5]厦门市中医院骨科 [6]上海交通大学药学院 [7]北京长寿俱乐部

出　　处：《中国骨与关节损伤杂志》2019年第1期25-28,共4页Chinese Journal of Bone and Joint Injury

基　　金：厦门市海洋经济创新发展区域示范项目(12CZP003SF05)

摘　　要：目的评价国产蓝湾高纯度硫酸氨基葡萄糖治疗膝关节骨性关节炎的有效性和安全性。方法纳入自2017-08—2018-04北京地区和厦门地区126例膝关节骨性关节炎,随机分为3组,每组42例。A组口服国产蓝湾高纯度硫酸氨基葡萄糖(300 mg/粒,硫酸氨基葡萄糖含量为99.3%),早3粒,晚2粒。B组口服国产蓝湾高纯度硫酸氨基葡萄糖,早、中、晚各3粒。C组为对照组,口服进口硫酸氨基葡萄糖胶囊(维固力,250 mg/粒,硫酸氨基葡萄糖含量为79.6%),早、中、晚各2粒。治疗12周,停药后继续观察4周。结果治疗12周时A、B、C组Lequesne评分较治疗前明显降低,差异有统计学意义(P <0.05)。治疗12周,A组与B组治疗有效率均高于C组,差异有统计学意义(P <0.05)。治疗12周以及停药2、4周时,A组与B组Lequesne评分均低于C组,差异有统计学意义(P <0.05);但A组与B组比较差异无统计学意义(P>0.05)。高纯度硫酸氨基葡萄糖治疗膝关节骨性关节炎药效至少可以维持到停药后4周。服药期间患者血压、脉搏、血常规、尿常规、肝功能、肾功能、血糖、尿酸等指标未见异常,仅个别患者出现轻微不良反应。结论国产蓝湾高纯度硫酸氨基葡萄糖治疗膝关节骨性关节炎的安全性及效果良好,尤其是在改善症状方面的效果优于硫酸氨基葡萄糖复盐。Objective To evaluate the efficacy and safety of domestic Lanwan high purity glucosamine sulfate(HPGS) in the treatment of knee osteoarthritis(OA). Methods All 126 cases of knee OA were selected and randomly divided into 3 groups,42 cases in each group from August 2017 to April 2018, in Beijing and Xiamen district. Group A was orally treated with domestic Lanwan HPGS(300 mg/capsule, content of glucosamine sulfate is 99.3%), with three capsules in the morning and two in the evening. Group B was orally treated with domestic Lanwan HPGS for three times a day, three capsules for each time.Group C was the control group, orally treated with imported glucosamine sulfate capsules(WEIGULI, 250 mg/capsule, content of glucosamine sulfate is 79.6%), with the dosage of 2 capsules each time, and three times a day as described. They were orally treated for 12 weeks and were assessed for drug efficacy and safety for 4 more weeks after discontinuation. Results After the treatment of 12 weeks, the Lequesne scores of group A, B and C were significantly lower than before treatment, and the difference was statistically significant(P <0.05). After the treatment of 12 weeks, the effective rates of group A and group B were all higher than group C, and the statistical difference were significant(P <0.05). The Lequesne scores of group A and B were lower than group C after the treatment of 12 weeks and after discontinuation of 2 and 4 weeks, and the statistical difference were significant(P <0.05). There was no statistically significant between group A and B(P >0.05). Lanwan HPGS maintained good efficacy in the treatment of knee OA, which could be maintained at least 4 weeks after discontinuation. During the treatment, there were no abnormal symptoms in the patients’ blood pressure, pulse, blood routine, urine routine, liver function,renal function, blood sugar, uric acid and other indicators, and only a few patients had slight side effects. Conclusion Domestic Lanwan high-purity glucosamine sulfate not only shows obvious safety, but als

关 键 词：膝关节 骨性关节炎 高纯度硫酸氨基葡萄糖 硫酸氨基葡萄糖复盐 

分 类 号：R684.3[医药卫生—骨科学]